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A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

NCT01091116 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2013-02-18

Study results available
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Summary

The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

MEN16132 - 0.125 mg

Intra-articular administration of two low doses of MEN16132 at 2-week interval.

DRUG

MEN16132 - 0.25 mg

Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval

DRUG

MEN16132 - 0.5 mg

Intra-articular injection of two high doses of MEN16132 at 2-week interval

DRUG

MEN16132 - 0.5 mg

Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval

DRUG

Placebo

Intra-articular injection of 2 doses of Placebo control at 2-week interval

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Karel Pavelka, Prof MD · Institute of Rheumatology, Charles University Prague

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-02-28
Completion
2011-03-31

Countries

  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01091116 on ClinicalTrials.gov